DESCRIPTION: State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving these goals. Avoid summaries of past accomplishments and the use of the first person. This abstract is meant to serve as a succinct and accurate description of the proposed work when separated from the application. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. This competing application seeks to renew the didactic Clinical Research Methodology Curriculum (CRMC) at Memorial Sloan-Kettering Cancer Center (MSKCC). Faculty from the Departments of Anesthesiology and Critical Care, Epidemiology and Biostatistics, Medicine, Surgery, Radiation Oncology, Pediatrics, Neurology, Urology, Psychiatry and Behavioral Sciences will participate in a two-year, multidisciplinary program that provides the didactic course work and fundamental skills required for a successful career as an independent clinical researcher. The proposed curriculum represents a substantial enhancement and programmatic evolution from the initial application. Four didactic research methodology modules provide comprehensive and in-depth instruction in the methodology and theory fundamental to sound clinical research. They include: 1) Investigational drug and medical device development from pre-clinical testing to FDA approval; 2) Clinical research in outcomes analysis, psychometric measurements, biological markers, and epidemiology; 3) Ethical conduct, regulations involving human subject research, data management, reporting responsibilities, institutional oversight, and conflict of interest in clinical investigations; 4) Clinical trial designs, integration of correlative sciences, ethical considerations, and regulatory oversight. The curriculum also includes a course in biostatistics and highly interactive workshops in both grant writing and clinical protocol development that provide additional training in hypothesis testing and clinical trial methodology. Since its inception, the program has been successful in achieving its goal of training independent clinical researchers in diverse disciplines including Obstetrics and Gynecology, Orthopedic Surgery, Otolaryngology, General Surgery, Urology, Oncology, Pediatric Oncology, Neurology, Psychiatry and Behavioral Sciences, and Radiation Oncology. These investigators have outstanding records of academic matriculation and extramural funding for their clinical research and have published over 300 manuscripts. The independent clinical investigators trained by this curriculum are already emerging leaders in biomedical research, providing intellectual leadership as Principal or Co-Principal Investigators for 75 IRB-approved research protocols nationwide. This competitive renewal demonstrates our substantial commitment to the training of clinical investigators and the success of the CRMC in achieving that goal. PERFORMANCE SITE(S) (organization, city, state) Sloan-Kettering Institute for Cancer Research 1275 York Avenue New York, NY 10021 KEY PERSONNEL. See instructions. Start with Principal Investigator. List all Name Bajorin, Dean F, MD Spriggs, David, MD Wilson, Roger, MD Andrew Vickers, PhD David Pfister, MD Fong, Yuman, MD Heaney, Mark, MD, PhD Use continuation pages as needed other key personnel in alphabetical Organization Department of Department of Department of to provide the required information order, last name first. Medicine Anesthesiology Medicine Dept of Biostatistics and Epidemilogy Department of Medicine Department of Surgery Department of Medicine in the format shown below. Role on Project Principal Investigator Co-Principal Investigator Co-Principal Investigator Key Faculty Key Faculty Key Faculty Key Faculty Disclosure Permission Statement. Applicable to SBIR/STTR Only. See instructions. [] Yes [] No PHS 398 (Rev. 05/01) Page 2 Form Page 2 2 Faculty Matthew Ball, BA Richard R. Barakat, MD Colin B. Begg, PhD Steve Bertha, PhD George J. Bosl, MD Jay Owen Boyle, MD Renier J. Brentjens, MD, PhD Barrie Casileth, PhD Paul B. Chapman, MD Nai Kong Cheung, MD, PhD Elena Elkin, MPA, PhD Collette M. Houston, BA Clifford A. Hudis, MD Arti Hurria, MD Joseph G. Jurcic, MD Michael Kattan, MBA, PhD Jean Kelly, BSN Mark G. Kris, MD Diana E. Lake, MD Marguerite S. Lederberg, MD Philip O. Livingston, MD Machuchhanda Mazumdar, PhD Bruce Minsky, MD Robert Motzer, MD Owen O'Connor, MD PhD Kenneth Offit, MD, MPH Adam Olshen, PhD Richard O'Reilly, MD Jamie Ostroff, PhD Eric Pamer, MD Richard Payne, MD Bruce D. Rapkin, PhD Neal Rosen, MD Valerie Rusch, MD Michel Sadelain, MD, PhD Peter T. Scardino, MD David Scheinberg, MD, PhD Howard Scher, MD Deborah Schrag, MD, MPH Sidney J. Winawer, MD Robert E. Wittes, MD Jedd D. Wolchok, M D, PhD Ann G. Zauber, PhD Michael Zelefsky, MD Bajorin, Faculty Participants Department Office of Sponsored Projects Dept. Surgery Dept. Epidemiology & Biostatistics Office of Industrial Affairs Dept. of Medicine Dept. of Surgery Dept. Medicine Dept. Medicine Dept. Medicine Dept. Pediatrics Dept. Epidemiology & Biostatistics Office of Clinical Research Dept. Medicine Dept. Medicine Dept. Medicine Dept. Epidemiology & Biostatistics, Dept. Urology Dept. Medicine Dept. Medicine Dept. Medicine Dept. Psychiatry Dept. Medicine Dept. Epidemiology & Biostatistics Dept. Radiation Oncology Dept. Medicine Dept. Medicine Dept. Medicine Dept Epidemiology & Biostatistics Dept. Pediatrics Dept. Psychiatry Dept. Medicine Dept. Medicine Dept. Psychiatry Dept. Medicine Dept. Thoracic Surgery Depts. Medicine & Pediatrics Dept. Urology Dept. Medicine Dept. Medicine Dept. Medicine Dept. Medicine Physician-in-Chief, Office of Clinical Research Dept. Medicine Dept. Epidemiology & Biostatistics Dept. Radiation Oncology Dean F, MD Role Participating Faculty Nominating Faculty Advisory Committee Curriculum Faculty Advisory Committee Curriculum Faculty Curriculum Faculty Nominating Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Advisory Committee Nominating Faculty Curriculum Faculty Nominating Faculty Nominating Faculty Curriculum Faculty Curriculum Faculty Advisory Committee Nominating Faculty Curriculum Faculty Curriculum Faculty Advisory Committee Curriculum Faculty Curriculum Faculty Curriculum Faculty Advisory Committee Curriculum Faculty Curriculum Faculty Curriculum Faculty Curriculum Faculty Nominating Faculty tsajonn,tJeanr. IvIIA Tableof Contents Face Page ........... ........................................................................................................................................................ 1 Description, Performance Sites, and Personnel ...................................................................................................... 2-3